Infection, BacterialNCT06379061
Access MeMed BV Assay Clinical Study Collection Protocol - Infectious Adult and Pediatric Cohorts
An observational study of Infection, Bacterial and Infection Viral, run by Beckman Coulter, Inc. at 4 sites in United States.
Trial summary
The purpose of the pivotal study is to collect blood specimens and clinical data from pediatric (>90 days old) and adult (≥18 years old) patients presenting with signs and symptoms suggestive of acute bacterial or viral infection. Read more about this study
- Who is it for?
- Ages 90 days to 89 years
- Conditions the study is for
- Infection, Bacterial, Infection Viral
- What is being tested?
- Adult and Pediatrics
- How many people
- 650 participants
- Where
- 4 sitesUnited States
- Study dates
- 12 Jun 2024to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 90 days to 89 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pediatric and adult patients presenting to the Emergency Department or Urgent Care Center with signs and symptoms suggestive of acute bacterial or viral infection. The study sample size will be divided into the following: * Pediatric (>90 days - <18 yrs. of age) population sample target of 30 enrolled subjects. * Adult (≥18 yrs. of age) population sample target of 214 adult patients enrolled subjects. The target population will be representative of US demographics. This sample size aligns with comparator device studies. Pediatric sample collection will be separated into the following three (3) age categories: * Age over 90 days to <2 yrs. * Age 2 yrs. to <12 yrs. * Age 12 yrs. to <18 yrs.
Who may be able to join
- Over 90 days of age.
- Clinical suspicion of acute bacterial or viral infection.
- Temperature ≥ 37.8°C (100°F) (any body site, any measurement device, including self-reported) or tactile fever, either of them noted at least once within the last 7 days.
- Current disease duration ≤ 7 days.
Who cannot join
- Previously enrolled
- Insufficient sample volumes obtained
- For the adult and pediatric populations, < 1.2 mL serum volume
- Sample handling errors
- Another unrelated episode of febrile infection within the past 2 weeks
- Suspicion and/or confirmed diagnosis of infectious gastroenteritis/ colitis.
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- ≥48 hours of oral antibiotic treatment
- ≥12 hours of intravenous\intramuscular antibiotic treatment
- Human Immunodeficiency Viruses (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection (self-declared or known from medical records)
- A proven or suspected infection on presentation with Mycobacterial (e.g., Tuberculosis, MAC), parasitic or fungal (e.g., Candida, Histoplasma, Aspergillus) pathogen
- Active inflammatory disease (e.g., Inflammatory Bowel Disease [IBD], Systemic Lupus Erythematosus [SLE], Juvenile Idiopathic Arthritis [JIA], Rheumatoid Arthritis [RA], Kawasaki, other vasculitis)
- Major trauma and\or burns in the last 7 days.
- Major surgery in the last 7 days
- Congenital immune deficiency (CID)
- Acquired immune deficiency\modulation state including
- Active malignancy treated within last 6 months
- Current treatment with immune-suppressive or immune-modulating therapies, including without limitations:
- Administration of P.O.\IV\IM high dose steroids >1mg/kg/day prednisone (or equivalent) at some point in the past 10 days or daily continuous use of steroids > 0.25 mg/kg/day in the past 7 days ii. Monoclonal antibodies, anti-TNF agents iii. Intravenous immunoglobulin (IVIG) iv. Cyclosporine, Cyclophosphamide, Tacrolimus, Azathioprine, Methotrexate v. G/GM-CSF Interferons c. Post solid organ/bone marrow transplant patients d. Asplenia, sickle cell disease
- Indwelling central venous catheter
- Cystic Fibrosis
- Pregnancy - self-reported or medically known
- Other severe illnesses that affect life expectancy and quality of life such as:
- Severe psychomotor retardation
- Congenital metabolic disorder
- End stage renal disease, advanced heart failure (NYHA 3/4), advanced COPD (GOLD 3/4)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Massachusetts General Brigham
Boston, Massachusetts, 02114
Wayne State University
Detroit, Michigan, 48202
Indiana University School of Medicine
Indianapolis, Indiana, 46202
About this study
The purpose of the pivotal study is to collect blood specimens and clinical data from pediatric (>90 days old) and adult (≥18 years old) patients presenting with signs and symptoms suggestive of acute bacterial or viral infection. These samples will be used to establish the diagnostic performance of MeMed BV™ for differentiating bacterial from viral infection using method comparison and/or method concordance.
Read the detailed description
The objective of this study is to collect blood specimens from pediatric (>90 days old) and adult patients (≥18 years old) presenting with signs and symptoms suggestive of acute bacterial or viral infection from hospital, Emergency Department, or Urgent Care Centers for comparative testing on the Access 2 and DxI 9000 Immunoassay Analyzers.
- Conditions
- Infection, Bacterial, Infection Viral
- Being tested
- Adult and Pediatrics
- Medical subject headings
- Bacterial Infections, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adult and PediatricsOther
This is an observational study. This protocol is for blood draw enrollment. These samples will be collected and binned by their results from the MeMed BV assay. Samples collected will be used for an analytical comparison study under a future testing protocol. These samples will be used to establish the diagnostic performance of MeMed BV test on BEC Access Immunoassay Systems for differentiating bacterial from viral infection.
| Study group | Role | What they receive |
|---|---|---|
| Adult and Pediatrics | A minimum of 244 serum samples will be collected at a minimum of two (2) US locations from enrolled pediatric and adult patients presenting signs and symptoms suggestive of acute bacterial or viral infection. The number of patients enrolled is based on total volume required to run analytical comparison studies under a future testing protocol. Receives: Other: Adult and Pediatrics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Specimen Collection
Collect blood specimens across multiple age ranges presenting symptoms of acute or viral infection
Measured: Less or equal to seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start12 Jun 2024
- Primary completion31 Jan 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, BacterialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 650 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beckman Coulter, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MeMed Diagnostics Ltd.
- Responsible party
- Sponsor
- Investigators
- David Haan, Study director, Beckman Coulter, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379061
- Sponsor's protocol ID
- MM-01-24
- Other IDs
- MMP-01-24
- Status last verified
- Jun 2025
- First submitted
- 18 Apr 2024
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Access MeMed BV Assay Clinical Study Collection Protocol - Infectious Adult and Pediatric Cohorts
- ClinicalTrials.gov ID
- NCT06379061
- Acronym / sponsor ID
- MM-01-24
- Conditions
- Infection, Bacterial, Infection Viral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 650 participants (actual)
- Lead sponsor
- Beckman Coulter, Inc.Industry (pharma, biotech, devices)
- Collaborators
- MeMed Diagnostics Ltd.
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 23 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the pivotal study is to collect blood specimens and clinical data from pediatric (>90 days old) and adult (≥18 years old) patients presenting with signs and symptoms suggestive of acute bacterial or viral infection. These samples will be used to establish the diagnostic performance of MeMed BV™ for differentiating bacterial from viral infection using method comparison and/or method concordance.
Detailed description
The objective of this study is to collect blood specimens from pediatric (>90 days old) and adult patients (≥18 years old) presenting with signs and symptoms suggestive of acute bacterial or viral infection from hospital, Emergency Department, or Urgent Care Centers for comparative testing on the Access 2 and DxI 9000 Immunoassay Analyzers.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult and Pediatrics | – | Other: Adult and PediatricsA minimum of 244 serum samples will be collected at a minimum of two (2) US locations from enrolled pediatric and adult patients presenting signs and symptoms suggestive of acute bacterial or viral infection. The number of patients enrolled is based on total volume required to run analytical comparison studies under a future testing protocol. |
Who may qualify
- Ages
- 90 days to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pediatric and adult patients presenting to the Emergency Department or Urgent Care Center with signs and symptoms suggestive of acute bacterial or viral infection. The study sample size will be divided into the following: * Pediatric (>90 days - <18 yrs. of age) population sample target of 30 enrolled subjects. * Adult (≥18 yrs. of age) population sample target of 214 adult patients enrolled subjects. The target population will be representative of US demographics. This sample size aligns with comparator device studies. Pediatric sample collection will be separated into the following three (3) age categories: * Age over 90 days to <2 yrs. * Age 2 yrs. to <12 yrs. * Age 12 yrs. to <18 yrs.
Key inclusion criteria (4 listed)
- Over 90 days of age.
- Clinical suspicion of acute bacterial or viral infection.
- Temperature ≥ 37.8°C (100°F) (any body site, any measurement device, including self-reported) or tactile fever, either of them noted at least once within the last 7 days.
- Current disease duration ≤ 7 days.
Key exclusion criteria (25 listed)
- Previously enrolled
- Insufficient sample volumes obtained
- Sample handling errors
- Another unrelated episode of febrile infection within the past 2 weeks
- Suspicion and/or confirmed diagnosis of infectious gastroenteritis/ colitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adult and PediatricsThis is an observational study. This protocol is for blood draw enrollment. These samples will be collected and binned by their results from the MeMed BV assay. Samples collected will be used for an analytical comparison study under a future testing protocol. These samples will be used to establish the diagnostic performance of MeMed BV test on BEC Access Immunoassay Systems for differentiating bacterial from viral infection. | Other | Adult and Pediatrics |
Primary outcome
Blood Specimen Collection
Time frame: Less or equal to seven days
Collect blood specimens across multiple age ranges presenting symptoms of acute or viral infection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Haan study director
Beckman Coulter, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, Bacterial and Infection Viral, run by Beckman Coulter, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Specimen Collection (time frame: Less or equal to seven days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.